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Safety in a FIH trial is managed pro-actively it's built into the design from day one

Sterile water and normal saline can technically dissolve the powder, but the reconstituted solution must then be used within 24 hours, which is impractical for a weekly injection regimen
Certain cancers, especially those of the stomach, pancreas, or blood (such as leukemia or lymphoma), can impact available Vitamin B12 by either blocking or disrupting the bodys absorption and/or increasing the physiological need for Vitamin B12

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Moreover, FDA advertising regulations apply only to manufacturers, packers, or distributors, designations that do not appear to capture the novel business entities, such as telehealth platforms or medical spas, that are now commonly advertising and prescribing prescription drugs to consumers (Moore & Alexander, 2023)

Learn what bacteriostatic water is and why it's considered safe before you start
